Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Inclusion Criteria:

• Patients with type 2 diabetes mellitus
• Patient is not pregnant or breastfeeding
• Male or female patient unlikely to conceive
• Patient not on an antihyperglycemic drug

Exclusion Criteria:

• Patient has history of type 1 diabetes mellitus
• Patient has history of ketoacidosis
• Patient requires insulin within 8 weeks prior to start of study
• Patient on weight loss program and is not in maintenance phase
• Patient taking weight loss medication within 8 weeks prior to start of study
• Patient on or likely to require = 14 days or repeated courses of corticosteroids
• Patient taking immunosuppressive/immunomodulating medication
• Patient taking digoxin or other cardiac medication
• Patient has undergone surgical general anesthesia within 30 days prior to start of study
• Patient taking investigational drug within 8 weeks prior to start of study
• Patient is diagnosed with liver disease
• Patient has chronic myopathy, progressive neurological/neuromuscular disorder
• Patient has with severe cardiac conditions within the last 6 months
• Patient is Human immunodeficiency virus (HIV) positive
• Patient has hematological disorder
• Patient has history of malignancy
• Patient has history of alcohol or drug abuse within the past 3 years